DRCR.net Image Acquisition Protocol

DRCR.net Image Acquisition Protocol Optical Coherence Tomography Angiography (OCT-A) Using: Optovue AngioVue Version 3.0 August 14, 2017 DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17

Table of Contents 1. Optovue OCT Angiography (OCT-A) Overview... 3 OCT-A Technician Certification... 5 2.1 Overview... 5 Patient Management... 6 Scan Acquisition: Steps to Acquire OCT Angiography Scans... 9 4.1 AngioVue Scan... 9 4.2 Scan Optimization... 12 4.3 Follow-up Mode...16 4.4 Tracking Mode.16 Setting up the Study Protocol... 17 Exporting... 19 6.1. Renaming Subjects prior to Export... 19 6.2 Exporting Data Files... 20 DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 2 of 24

Version History Version Author Approver Effective Date Revision Description 1.0 Adam Glassman Lee Jampol 28 July 2016 Initial version of document 2.0 Adam Glassman Cindy Stockdale 19 September 2016 Optovue will certify imagers; exports should be uploaded not zipped, formatting fixes and minor clarifications added 3.0 Julie Davis Adam Glassman 14 August 2017 Casey Reading Center will certify imagers and equipment. Addition of HD retina and disc scan 1. Optovue OCT Angiography (OCT-A) Overview a. Machine: Optovue Avanti XR AngioVue b. Certification for OCT-A imaging will be performed through the Casey Reading Center c. Scan Type: Two scan settings on the macula: 3x3 mm scan and HD 6x6 mm scan centered on the fovea. Each scan setting should include both x-fast AND y-fast images. One scan setting for the optic nerve: HD 4.5x4.5 centered on the optic nerve. The scan for the HD 4.5x4.5 should include both x-fast AND y-fast images. Ancillary Images (if requested): One additional 6x6 mm scan (non-hd) centered on the fovea; one additional 4.5 x 4.5 (non-hd) centered on the optic nerve. d. Select the PATIENT window from the main menu. Select an existing patient or add a new patient. e. Click the Scan button to go to the SCAN window. f. In the SCAN window, select the patient eye to be scanned; Both/OU or Right/OD or Left/OS. g. If the DRCR network protocol has been created on your device including the HD scans, click the protocol the list of required scans should appear in the patient s window. If the DRCR network protocol has not been created on your specific device or if all the required scans are not checked, check all the AngioVue OCT Angiography scans that need to be captured. Then in the completed scan window, all selected scans will be displayed with capture number labeled beside. h. To start a selected scan, use the mouse to double click any selected scan from the completed scan window. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 3 of 24

i. In the new version of eye tracking software, Eye Alignment pop up window will show up. j. Adjust table height to accommodate the subject comfortably as needed. k. Have the subject place his/her chin into the correct chin cup with forehead leaning against the forehead rest l. Align eye to be scanned vertically with the canthus mark on the side of the chin rest assembly m. Ask the patient to look at the fixation target, a blue/white dot in the red field. n. Center the video image on the pupil and move the scan head towards the patient, controlling it so that the video image passes through the pupil. Carefully advance until the fundus come into view. Figures below show the progression of views as you move the scan head forward. The box (the scanning region) on the right panel can also be dragged to the location to best center the image provided the Follow-Up box is unchecked. This is particularly important for patient with eccentric fixation. o. Adjust the working distance between the scan head and the patient eye to optimize the video image. Optimized fundus images should show Optic nerve head clearly visible and fundus image is illuminated evenly from edge to edge. p. When the video image is optimized, click Auto Adjust button in the new tracking software (or Auto All button) to adjust Polarization, Z offset, and Focus. q. The enface OCT image as well as the line scan OCT image will show up in two different windows. r. Use the mouse wheel to adjust the line OCT image between the two red lines with correct orientation. s. If the OCT Quality indicator bar on the right is not green, adjust the Z axis, Focus or P- Motor functions until the SSI indicator is green. t. Capture image - click the joystick button or the on screen green check mark (Once the joystick button or green check mark is clicked do not try to adjust the live OCT image by moving the station in and out) DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 4 of 24

u. When the 1st OCT Angiography has been captured, a pop-up window will show up and ask if you want to continue to the 2nd MCT (OCT Angiography) scan. At this step, the technician should check the image quality and decide to Continue or Rescan the 1st scan one more time. v. If the 1st scan quality is fine, click Continue button. w. Capture image - click the joystick button or the on screen green check mark x. When the 2nd OCT Angiography is captured, a pop up window will ask if you want to continue to the MCT processing and save. At this step, the technician should check the image quality and decide to Continue and Save or Rescan the 2nd scan one more time. y. When the 2nd scan quality is fine, click Continue and Save button. z. Please review the OCT Angiography image from the Review tab. If a scan has poor saturation or is of poor quality, have the subject blink or apply artificial tears, and repeat the scan. The Signal Strength (SSI) should be above 55. If the SSI is below 30, the RTVue will not save the data. aa. All images will be exported via the DRCR.net uploader Further clarification regarding any information included in this document may be obtained by contacting the DRCR.net Coordinating Center drcrnet@jaeb.org or 813-975-8690 or the Casey Reading Center at readingcenter@ohsu.edu or (503) 418-2189. OCT-A Technician Certification 2.1 Overview Certification for both the equipment and technicians will be required and performed through the Casey Reading Center. Requests for OCTA equipment certification must be made on the DRCR.net website under Clinical Sites Certification OCT Angiography Technician Certification Request Form. The request form contains a link to an Equipment Certification Form. Sites will need to complete and submit the Equipment Certification Form to readingcenter@ohsu.edu. Only one form is needed per OCTA machine. Requests for OCTA certification must be made on the DRCR.net website under Clinical Sites Certification OCT Angiography Technician Certification Request Form. Technicians will need to choose between OCTA-Zeiss and OCTA-Optovue certification. If a site has both the Optovue AngioVue and the Zeiss AngioPlex, the technician will need to request certification for both procedures. The technician must indicate whether they are requesting grandfather certification by selecting Yes or No for the question Is technician requesting certification based upon DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 5 of 24

current certification(s). Technicians who have already obtained OCTA images in a DRCR.net study should select Yes. OCTA certification images will be submitted on the Casey Reading Center website. Upon submission of the OCT Angiography Technician Certification Request Form on the DRCR.net website, an email with login access to the Casey Reading Center site will be issued to technicians who need to submit images for certification. The image types needed for certification are listed on the OCT Angiography Technician Certification Request Form. It is important to note that an email should be sent to readingcenter@ohsu.edu acknowledging that all the image files have been submitted on the Casey Reading Center site. The request form also contains a link to a Staff Certification Form. Technicians who have obtained OCTA images in a DRCR.net trial should check the Requesting Prequalification box on the form and specify the participant ID and visit date on whom images were taken. These technicians should not need to upload separate OCTA files for certification. Technicians will need to complete and submit the Staff Certification Form along with their curriculum vitae to readingcenter@ohsu.edu. OCTA technician certifications are valid for one year from issuance date with renewal based on technicians obtaining at least one image per year and meeting the quality standards set by the Casey Reading Center. Questions regarding OCTA technician and equipment certification should be directed to the Casey Reading Center at (503) 418-2189. Patient Management 3.1 Manage Patient Information The system application opens by default to the PATIENT window. 3 4 5 6 7 1 2 13 12 11 10 9 8 DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 6 of 24

Figure 1 PATIENT Window Items Figure 1 Legend: 1. PATIENT tab (highlighted) 2. Basic or Advanced Search area 3. Selected patient in list and on title bar 4. Patient list 5. Patient Detail area 6. Visit list (for selected patient) 7. Scan list (for selected visit) 8. Review button 9. OD and OS Retina OverVue buttons 10. Scan button 11. Edit button 12. Add Patient button 13. Advanced or Basic Search link Use the PATIENT window to create, find, select, edit and delete patients, visits and scans, and to initiate scanning or scan review. Features of the PATIENT window help you enter patient information in advance, preview today s scheduled patients, and search for patients using a specified date range or other search criteria. The PATIENT list displays search results. 3.2 Add a New Patient To add a new patient, click the Add Patient button. The Add New Patient dialog appears, as shown in Figure 2. Figure 2 Add New Patient Dialog 1. Required fields are in bold. Enter the required information and enter other information as desired. You must enter the birth date in the indicated format. 2. Trial participants should be entered as follows: DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 7 of 24

First name: Trial name (ex DRCR-AA) Last name: Participant ID (ex. AA221-0328) Patient ID: Participant ID (ex. AA221-0328) Date of birth: 01/01/1900 3. Use the Optional area to enter: Physician: Use the down arrow to select one or more physicians to associate with this patient, or select Add New to enter a new physician name and associate it with this patient. Operator: Use the down arrow to select one or more operators to associate with this patient, or select Add New to enter a new operator name and associate it with this patient. Visit Comment: Enter desired comments for this patient. 4. Note: You can also create, edit and delete physicians, operators or diseases by selecting Physician, Operator or Disease from the Database Management menu. 5. Use the Disease Category area to associate one or more user-defined diseases with this patient. Once they are created, you can search for patients by disease category. To create disease categories, click Add New to display the Disease Category Editor dialog, enter a disease name and click OK. 6. When you finish entering information for the new patient, click Save to save the new patient and close the dialog, or click Scan to initiate scanning for this new patient. Click Cancel to discard entered information and close the dialog. 3.3 Edit Patient Information 1. To edit patient information, select the patient name from the Patient list and click the Edit button. The Edit Patient/Visit Info dialog appears. 2. Edit the fields as desired. 3. Click Save to save your changes. 4. Click Cancel to discard the edits and close the dialog. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 8 of 24

Figure 3 Edit Patient Dialog Scan Acquisition: Steps to Acquire OCT Angiography Scans Note: We recommend you clean the chinrest and forehead rest between patients with a disinfectant. For example, wipe with an isopropyl alcohol pad or with another germicide using a clean cloth. 4.1 AngioVue Scan 1. Scan Window (older models may have different view) a. From the PATIENT window, select an existing patient or add a new patient, then click the Scan button to go the SCAN window (Fig. 4) 2. Scan Parameters a. In the SCAN window, select the patient eye to be scanned. Both/OU is selected by default. To change, click the Right/OD or Left/OS button. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 9 of 24

Figure 4 Scan Selection Options b. Select the AngioVue OCT Angiography scan type, Angio Retina 3.0 mm, HD Angio Retina 6.0 mm, and HD Angio Disc 4.5mm scans. If non-hd scans are also required, additionally select Angio Retina 6x6 mm and Angio Disc 4.5mm. When you finish your selections, click the Scan button to begin scanning. Ensure that both the x-fast and y-fast images are obtained for each of the scan settings above. a. A scanning protocol can also be created to use in the future by clicking Database Management => Protocol => Add (see Section 5 below for additional details on creating a protocol). Once a scanning protocol is created it can be used by selecting the Scan Selection tab c. During the follow up scanning, the operator should repeat any previous scan for a patient by double-clicking on the scan name in the Scans list of the PATIENT window. d. Position the patient correctly as follows: Chin on the system chin rest with teeth together Forehead against the forehead rest Eye to be scanned aligned vertically with the canthus mark on the side of the forehead and chin rest assembly. Ask the patient to look at the fixation target, a blue/white dot in the red field. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 10 of 24

e. Center the video image on the pupil and move the scan head towards the patient, controlling it so that the video image passes through the pupil. Carefully advance until the fundus comes into view. The figure below shows the progression of views as you move the scan head forward. Figure 5 Video Image Progression as Scanner Approaches Eye f. Once patient is in correct position and image has been advanced, click Auto Adjust as prompted by the Pop up window. g. Capture the image by selecting the green check mark to acquire the image. Please be sure the green light is on for Tracking. Evaluate the the Angiovue enface image for scan quality when complete. Acceptable quality scan should not have eye movement, double vessels, or avoidable media opacity artifacts. The enface image should have well focused vasculature with 4 or less bright lines for acceptable image quality. Black lines representing blinks should be minimal. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 11 of 24

4.2 Scan Optimization a. Adjust the working distance between the scan head and patient eye and position side-toside to optimize the video image. Optimized fundus images and optic disc images should be illuminated evenly from edge to edge. Note: For fundus imaging, make sure to set the working distance first. If a live OCT scan appears in the scan window, do not stop forward movement of the camera until you achieve a good infrared (IR) video image of the fundus. IR video image showing scan pattern overlay En face image Figure 7 Optimize Working Distance b. When the video image is optimized, Click Auto Adjust to optimize scan signal strength and image quality. A. B. Figure 8 Auto Adjust DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 12 of 24

Variable display of Auto Adjust option: A. Pop-up window may appear when aligning the IR image. B. Permanent button. Auto Adjust executes Auto Z, Auto F and Auto P in combination. Auto All also tries to place the scan image in the target area between the red dashed lines. Figure 8 shows an example of a scan centered vertically. If the scan is not between the red dashed lines but visible in the window, click once in the scan window and scroll the mouse wheel to bring the OCT scan between the red dashed lines. The image in Figure 7is also upside down, which means that the working distance was too close. In this case the joystick should be pulled back and Auto Adjust repeated so the scan is right side up. Green bar shows good signal strength Figure 9 Example of Scan Centered Vertically c. On the right side of each live scan, a green bar indicates a good signal strength index (SSI) value. To capture the scan, either press the joystick button or click the checkmark button. Once you click the joystick button or the on screen green check mark. Do not try to adjust the live OCT image by moving the station in / out / left / right. d. After the first scan capture (fast X), review the scan images for quality and completeness. Then continue to capture the fast Y scan, click the Continue button. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 13 of 24

Figure 10 Review Fast X scan (lower left) and Rescan or Continue and Capture OCT Angiography Fast Y Scan e. To capture the Fast Y scan, either press the joystick button or click the checkmark button. f. After the second scan capture (fast Y), review the scan images for quality and completeness. g. When both scans don t have black lines, click the Continue and Save button. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 14 of 24

Figure 11 Review OCT Angiography Fast Y Scan (upper right) and Rescan or Save Both Scans h. After the MCT merge the fast X and fast Y OCTA scans, the final OCT Angiography scan image is ready to review. The scan will be saved in the patient s file. Figure 12 Review complete OCTA images DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 15 of 24

i. When you are done one scanning, continue to capture other OCT Angiography scans for the patients. 4.3 Follow-up Mode Figure 13 Follow-up and Tracking Mode Buttons Follow-up mode should be used if possible, and is on when its checkbox is checked, and off when it is unchecked (see Figure ). When you are repeating a scan done on a previous visit for this patient, you should use Follow-up to repeat the scan location and rotation of the previous scan. Repeat scans using Follow-up cannot be moved or rotated. Turning Follow-up off allows you to move or rotate the scan. Follow-up mode does not take into account changes in fixation relative to the previous scan. Note: You may have to guide the patient s fixation to achieve alignment of the scan to the previous visit. In Follow-up mode, the cross-hair on the IR image is red if alignment is not correct, and green when alignment is correct. The capture button turns green only when the cross-hair is green, indicating correct alignment. If you need to scan a different location, turn off follow-up mode. NOTE: Sometimes even with correct alignment, cross hair remains red if signal to noise ratio is poor. In this case there is no choice but to turn off FOLLOWUP mode. 4.4 Tracking Mode Tracking helps to maintain scan placement when the patient blinks or moves their eye, and should be used if possible. Tracking is on when its checkbox is checked, and off when it is unchecked. A good IR image of the fundus is important when tracking is on, because the system tracks image details to maintain scan placement. Figure 16 below shows examples of good and poor IR fundus images. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 16 of 24

Figure 14 Good IR Image (Left) and Poor IR Image (Right) The capture button turns green only when a good fundus image is present. A small green cross on the IR image indicates good tracking, and a red cross indicates poor tracking. During scan capture, a small progress bar at bottom left shows scan progress. If scan capture takes longer than expected because tracking is on, you can turn tracking off during scan capture, and the system captures remaining scans with tracking off. Setting up the Study Protocol Create a protocol under Database Management tab to use this setting for the study. Select Retina or add Retina if it is not already present, then choose Add DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 17 of 24

Select HD Angio Retina 6.0mm and click Add. Click Save, then the window pops up asking the protocol name. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 18 of 24

Type the study name and now you have the study protocol. You can add the HD Angio disc scan (next section) to this protocol at the same time after the HD Angio Retina scan. After this initial protocol setup, you can click your protocol for the future scan acquisition. Exporting 6.1. Renaming Subjects prior to Export a. Identifying subject information must be anonymized before sending to the CRC. Select Patient tab and Edit. Enter anonymized information using the following format and select Save. Last Name: Study Name (ex: DRCR W) First Name: Subject ID (ex: W013-0001) Date of Birth: 1/1/1900 DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 19 of 24

6.2 Exporting Data Files a. Navigate to top left corner TOOLBAR > File > Data Transfer > Output Data b. A window will appear as seen below. Select destination to save the export. c. Create a new folder on the desktop by right clicking and selecting New > Folder. Name the new folder according to the labeling convention, click Save DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 20 of 24

d. A new screen will appear. To search for the correct subject, enter their name in the Search area (circled in red below). Then select Search. e. A list of patients that meet the search criteria will appear on the left side of the screen. Find the subject and select the correct visit date. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 21 of 24

f. Since patient names and identifiers are not in the OCT machine but patients are named based on study and site number, do not select anonymous on the export since this will re-name the patient. g. Select Start Output. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 22 of 24

h. The following screen will pop up if the export has successfully completed. Select OK. i. Select Save and Exit. You should see the following contents when you open the folder to which you exported the patient data. j. Run CleanDBData.bat from the C:\RTOCT\Tool. A window will appear asking the user to browse to a SQL Server output file. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 23 of 24

Point to the output file you created using XR Avanti software and click the Open button. The file should have extension.bak (refer to the screenshot above). After a few seconds the database should be cleaned. A success message should appear on the screen k. Upload the exported image folder with all three contents through the DRCR.net Upload Application. DRCR.net OCT-A Optovue AngioVue Procedure Manual 3.0 8-14-17 final Page 24 of 24